Background Sepsis is one of the most common causes of neonatal deaths globally. Most sepsis-related deaths occur in
low-income and middle-income countries, where the epidemiology of neonatal sepsis remains poorly understood.
Most of these countries lack proper surveillance networks, hampering accurate assessment of the burden of sepsis,
implementation of preventive measures, and investment in research. We report results of neonates born in hospital
from a multicentre collaboration on neonatal sepsis.
Methods In this cohort study, dedicated research teams prospectively followed up neonates born in one of three
tertiary care centres in Delhi, India (Vardhaman Mahavir Medical College, Maulana Azad Medical College, and All
India Institute of Medical Sciences [coordinating centre]) and subsequently admitted to the intensive care unit.
Neonates were followed up daily until discharge or death. On clinical suspicion, neonates underwent sepsis work-up
including blood cultures. The isolated organisms were identifi ed and tested for antimicrobial susceptibility. We
defi ned Gram-negative isolates resistant to any three of fi ve antibiotic classes (extended-spectrum cephalosporins,
carbapenems, aminoglycosides, fl uoroquinolones, and piperacillin-tazobactam) as multidrug resistant.
Findings 13 530 neonates of 88 636 livebirths were enrolled between July 18, 2011, and Feb 28, 2014. The incidence of
total sepsis was 14·3% (95% CI 13·8–14·9) and of culture-positive sepsis was 6·2% (5·8–6·6). Nearly two-thirds of
total episodes occurred at or before 72 h of life (defi ned as early onset; 1351 [83%] of 1980). Two-thirds (645 [64%])
of 1005 isolates were Gram-negative including, Acinetobacter spp (22%), Klebsiella spp (17%), and Escherichia coli (14%).
The pathogen mix in early-onset sepsis did not diff er from that of late-onset sepsis (ie, after 72 h). High rates of
multidrug resistance were observed in Acinetobacter spp (181/222, 82%), Klebsiella spp (91/169, 54%), and Escherichia coli
(52/137, 38%) isolates. Meticillin resistance prevailed in 61% (85/140) of coagulase-negative staphylococci and 38%
(43/114) of Staphylococcus aureus isolates. Nearly a quarter of the deaths were attributable to sepsis. The populationattributable
risks of mortality were 8·6% in culture-negative sepsis, 15·7% in culture-positive sepsis by multidrugresistant
organisms, and 12·0% in culture-positive sepsis by non-multidrug-resistant organisms.
Interpretation The high incidence of sepsis and alarming degree of antimicrobial resistance among pathogens in
neonates born in tertiary hospitals underscore the need to understand the pathogenesis of early-onset sepsis and to
devise measures to prevent it in low-income and middle-income countries